Electrocardiograms (ECGs) are widely used in clinical research to determine primary and secondary endpoints and, for example, to assess the effect of drug-induced relevant changes. The vast majority of such ECG analyses are performed either directly on paper ECG charts/printouts or using on-screen caliper methods applied to a displayed image of a scanned ECG paper chart/printout.
Advancements in technology are causing the health care industry as a whole to move increasingly toward the use of digital technologies. Digital technologies increase the efficiency with which data and images are stored, exchanged and analyzed. This general trend toward digital technologies is also being applied to ECGs. As an example, the Food and Drug Administration (FDA) has an initiative intended to encourage the use of digital ECGs in new drug applications submitted by pharmaceutical companies. Further, at least in part due to the predicted issuance of regulatory guidelines, there is likely to be a significant need for an efficient and widely acceptable method and system for the conversion of paper ECGs to digital ECGs.
The FDA initiative and predicted regulatory guidelines are likely to trigger the development of various tools for quantitative analysis of digital ECGs. For example, it is likely that the particular digital format chosen by the FDA for the submission of digital ECGs will be broadly adopted by the health care industry. Having a common or standardized digital ECG format will facilitate the interchange of ECG records among and between many entities.
Therefore, what is needed in the art is a method and system for deriving digital ECG waveforms from paper ECG charts/printouts and/or from ECG image files created by scanning such ECG paper charts/printouts.